NCT03591016

Brief Summary

This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

June 20, 2018

Last Update Submit

February 11, 2021

Conditions

Difficult Intravenous Access

Outcome Measures

Primary Outcomes (1)

  • Time it takes to insert an IV

    between 1 to 30 minutes

Secondary Outcomes (2)

  • Anticipated difficulty

    Baseline

  • Actual difficulty

    between 1 to 30 minutes

Study Arms (1)

Difficult intravenous access

Recording number of IV attempts in the operating room prior to surgery start.

Other: Recording number of IV attempts

Interventions

Recording number of IV attemptsOTHER

Recording number of IV attempts in the operating room

Difficult intravenous access

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.

You may qualify if:

  • Patients 0-18 years of age
  • Having surgery at Nationwide Children's Hospital

You may not qualify if:

  • Pre-existing IV upon arrival to the operating room

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Ralph Beltran, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 18, 2018

Study Start

July 2, 2018

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations

US(1)